The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion
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|ClinicalTrials.gov Identifier: NCT04843995|
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment|
|Stress Urinary Incontinence||Procedure: Mid-urethral sling|
This study is designed as a prospective cohort study. Our hypothesis is that mid-urethral sling provides backstop for excessive "swing motion" of distal urethra and helps with urethral compression along its luminal axis.
Aim 1: Investigate the effect of mid-urethral sling on the urethral shape at rest and maximum Valsalva, in other words dynamic urethral shape.
Aim 2: Compare the effect of mid-urethral sling on urethral dynamic shape in women with successful surgical outcome (absence of stress urinary incontinence at 3 and 12 months after the surgery) and women with surgical failure (presence of stress urinary incontinence at 3 and 12 months after the surgery).
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion|
|Actual Study Start Date :||January 11, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
- Procedure: Mid-urethral sling
Treatment of stress urinary incontinence with retropubic mid-urethral sling
- Urethral Shape at 3 months [ Time Frame: 3 months ]Urethral shape measured by ultrasound
- Urethral Motion at 3 months [ Time Frame: 3 months ]Urethral motion measured by ultrasound
- Urethral Shape at 12 months [ Time Frame: 12 months ]Urethral shape measured by ultrasound
- Urethral Motion at 12 months [ Time Frame: 12 months ]Urethral motion measured by ultrasound
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843995
|Contact: Joel D Winer, MDemail@example.com|
|Contact: Ghazaleh Rostami Nia, MDfirstname.lastname@example.org|
|United States, Illinois|
|NorthShore University HealthSystem||Recruiting|
|Skokie, Illinois, United States, 60076|
|Contact: Joel Winer, MD 224-251-2374 email@example.com|
|Principal Investigator:||Joel D Winer, MD||NorthShore University HealthSystem|
|Study Chair:||Ghazaleh Rostami Nia, MD||NorthShore University HealthSystem|